ANA and RF in direct-to-consumer free-for-all

6 minute read

The global DTC medical test market is booming, offering everything from fertility to child neurology checks – and even autoimmune testing, with no doctor input before ordering.

The unregulated direct-to-consumer (DTC) test market is booming, and increasingly puts vulnerable consumers at risk from dubious self-ordered tests for everything from fertility and small intestinal bacterial overgrowth to child neuropsychiatric conditions – and even rheumatology gets a look in. 

There’s an ‘autoimmune check’ for consumers who suspect they have some form of autoimmunity but want to bypass any medical review and go directly to testing, as well as rheumatoid arthritis and HLA-B27 tests.  

Direct-to-consumer tests are pathology tests offered to consumers that are directly purchased online, without needing a consultation with any medical doctor, and therefore not covered under Medicare.

The DTC market grew in value by a whopping 220% between 2010 and 2020, according to research presented at Pathology Update 2022, the annual scientific meeting for the Royal College of Pathologists of Australasia. 

Now, Australian pathologists have raised concerns about the lack of national regulation around tests offered for serious concerns, such as genetic testing and screening for cancer, autoimmune diseases, hormonal profiles and diabetes.  

“Maybe in the free market the test feels like empowerment, but maybe it is increasing vulnerability, which puts [consumers] at increased risk of harm (including physical, psychological and financial),” said Dr Patti Shih, a research fellow at the University of Wollongong.  

Meanwhile, rheumatologists would rightly be very concerned about home testing for autoimmune disease indicators.

One such test, an ‘autoimmune check’, measures antinuclear antibodies, rheumatoid factor, high sensitivity CRP, erythrocyte sedimentation rate and complement proteins C3 and C4. Blood samples are collected at an accredited partner pathology lab, with results reviewed and interpreted by ‘qualified medical professionals’ who’ll explain them to the consumer and recommend the next steps.

Also on offer in Australia are an ‘arthritis check’ (RF and ESR), a ‘rheumatoid arthritis test’ (RF) and an HLA-B27 test ‘to help assess the likelihood that you have an autoimmune disorder associated with the presence of HLA-B27.’

Another company allows you to choose your own tests from an extensive list, including all those listed above. Any ‘grossly abnormal’ results are reviewed by a medical professional and there may be further assistance.

Dr Shih said the global DTC test market size exploded from an estimated US$15.28 million (an estimated A$20.6 million in today’s dollars) to US$352.56 million (A$475 million) over the past decade. 

She said this trend of growth was expected to continue, especially given the advent of at-home rapid antigen testing for covid. 

“The expansion of RATs has given people an idea of the potential benefits [of DTC tests],” she said. 

“But we need to balance the benefits and harms that DTC tests can bring.” 

For some people who might not have otherwise sought health care, it could increase access to diagnostic tests and support patient empowerment in managing an established condition. But it could also result in overdiagnosis and overtreatment. False negatives could also result in missed treatment, Dr Shih said. 

Dr Sam Whittle, senior consultant rheumatologist at The Queen Elizabeth Hospital in Adelaide, said “Blood tests such as RF, ANA, complements and inflammatory markers have absolutely no role in either screening the healthy population or as part of a ‘self diagnosis’.

“Such testing clearly puts consumers at risk, in addition to the immediate financial loss, of overdiagnosis, underdiagnosis and psychological harm, and increases the likelihood of subsequent additional tests with associated financial costs and physical and psychological risks,” he said.

Dr Whittle pointed out that diagnostic tests such as autoantibody assays have a clear and important – but limited – role in the clinic, where they are used to refine the likelihood of potential clinical diagnoses following a careful clinical assessment.

“An understanding of this is fundamental to good medical practice, so one can only assume that any members of our profession offering such testing are doing so for commercial reasons rather than in the interests of good clinical care,” said Dr Whittle.

Clinical immunologist Dr Daman Langguth also raised these concerns, telling Rheumatology Republic that offering such tests without any knowledge of an individual’s health or potential medical issues goes against good medical practice.

“Many autoimmune diseases are complex and may be a challenge to diagnose, hence the importance of seeing a GP to discuss the symptoms that a patient has prior to embarking on any investigation,” said Dr Langguth.

A member of the research team investigating DTC tests, Dr Langguth added, “DTC testing for most diseases had very little supportive evidence to suggest it helps in healthcare.”

As part of the study, researchers searched Google between June and August 2021 to see what sort of tests were available to buy online. 

They found over 480 tests available in Australia, including home testing kits, self-sampled direct access tests and laboratory-sampled direct access tests. There was a wide variety of test types, from hair analysis to blood collection. 

Of the tests they found, half required a lab-collected sample, about one-third required a self-collected sample and the rest were home-based, self-test kits. 

Dr Shih said two-thirds of the tests were analysed in NATA-accredited (National Association of Testing Authorities) laboratories. Some were sent to overseas laboratories for analysis. Prices ranged from $13 to almost $2000.  

“Half of what we found was intended as wellness and lifestyle tests or health checks,” she told the conference. 

Dr Shih said there were probably many more tests available for purchase that did not require a referral from a health professional.

One of the most obscure tests she identified was a blood test for paediatric autoimmune neuropsychiatric disorders associated with streptococcus infections (PANDAS) – a rare neurological and psychiatric condition in which symptoms are brought on or worsened by a streptococcal infection. 

“It’s an antibody test, but to diagnose it correctly requires further psychiatric assessments,” she said. “So that targets the anxious parent.” 

She said there were some “really quite dodgy tests, like breath tests for SIBO – small intestinal bacterial overgrowth – which is less reliable than the gold standard test”. 

While there were major advantages to approved home-testing for things such as STIs, Dr Shih said the unregulated market was awash with tests that had the potential to exacerbate the vulnerability of patients in the absence of health professionals’ involvement. 

“I do worry that this market takes advantage of a certain type of vulnerability … I think that risk of harm is real.” 

She said there was a need in Australia to look at regulation and advertising standards around DTC tests, and this should occur with collaboration from the industry. Public awareness and education were also vital. 

“What we don’t know is who are using them and why … hopefully that’s going to be part of our research agenda, going forward,” said Dr Shih.  

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